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Saturday 23 February 2019
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Topic: Legislation &regulation

August 8, 2018
Senior clinicians will be able to legally prescribe cannabis-derived medicines this autumn, the Home Office has announced.

Senior clinicians will be able to legally prescribe cannabis-derived medicines this autumn, the UK's Home Office has announced.
 

August 8, 2018
New restricted indications on prescribing Esmya (ulipristal acetate) for symptoms of uterine fibroids have been put in place by the UK’s medicines watchdog

New restricted indications on prescribing Esmya (ulipristal acetate) for symptoms of uterine fibroids put in place by the UK’s medicines watchdog now replace instructions that the drug should not be prescribed to any new patients.
 

June 1, 2018
Health and Social Care Committee identifies key areas associated with childhood obesity, which demand urgent attention from government

The Health and Social Care Committee has called on the UK government to make it clear that childhood obesity is “everyone’s business”.

 

February 13, 2018
Draft NICE guidance paves the way for access to treatment with brodalumab on the National Health Service

LEO Pharma welcomes the news that the National Institute for Health and Care Excellence (NICE) has issued a Final Appraisal Determination (FAD) recommending the use of brodalumab 210mg for the treatment of adult patients with severe plaque psoriasis, as defined by a total Psoriasis Area and Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10, who have not responded to standard systemic therapies or who are unable to take them.1

 

April 4, 2016
If approved, TREVICTA® will be the first treatment for schizophrenia to be administered four times a year and will provide the longest dosing interval available for an antipsychotic medication in the European Union

March 21, 2016
The marketing approval of Enstilar® would make it the first fixed combination topical foam treatment for people living with psoriasis vulgaris in the EU

LEO Pharma announced that it received scientific approval of Enstilar® (calcipotriol/betamethasone dipropionate 50 micrograms/g / 0.5mg/g)  for the treatment of psoriasis vulgaris in patients 18 years of age or older. Enstilar® is an alcohol-free foam formulation for the topical treatment for psoriasis vulgaris.1

 

March 3, 2016
CONSTELLA® is the only available prescription treatment with a European Marketing Authorisation specifically for irritable bowel syndrome with constipation

Allergan, a leading global pharmaceutical company, announced that the European Commission has completed the transfer of the Marketing Authorisation for CONSTELLA® (linaclotide), a treatment for irritable bowel syndrome with constipation (IBS-C), from Almirall S.A. to Allergan Pharmaceuticals International Ltd.
 

March 1, 2016
Moventig is the first once-daily, oral peripherally acting mu-opioid receptor antagonist approved in Europe for the treatment of opioid-induced constipation in adult patients who have had an inadequate response to laxative(s)

ProStrakan Group, a subsidiary of Kyowa Hakko Kirin Co Ltd, and AstraZeneca announced that they have entered into an agreement for ProStrakan to acquire the rights to Moventig® (naloxegol) in the European Union (EU), Iceland, Norway, Switzerland and Liechtenstein. Moventig is the first once-daily, oral peripherally acting mu-opioid receptor antagonist (PAMORA) approved in Europe for the treatment of opioid-induced constipation (OIC) in adult patients who have had an inadequate response to laxative(s).
 

February 29, 2016
Briviact® (brivaracetam), a new add-on treatment for adults with epilepsy (aged 16 years and older) with partial–onset seizures (POS), with or without secondary generalised seizures, now available on the NHS

Briviact® (brivaracetam), a new add-on treatment for adults with epilepsy (aged 16 years and older) with partial–onset seizures (POS), with or without secondary generalised seizures, now available on the NHS.1

 


Epilepsy is the world’s most common serious neurological illness, affecting about 600,000 people in the UK. However it is not always controlled by medication,2,3 putting patients at risk of serious injury and even death (Sudden Unexpected Death in Epilepsy).4

February 29, 2016
Sobi and Biogen received a positive opinion from CHMP of the European Medicines Agency recommending that marketing authorisation be granted for Alprolix®

January 20, 2016
Novartis drug Entresto™ (sacubitril/valsartan) approved for use in adults with symptomatic chronic heart failure with reduced ejection fraction reduces mortality risk compared with current treatment according to study

Novartis announced Entresto™ (sacubitril/valsartan) for the treatment of adult patients with symptomatic chronic heart failure with reduced ejection fraction (HFrEF) is now available in the UK. Sacubitril/valsartan significantly reduces the risk of cardiovascular death and first hospitalisation for heart failure by 20% when compared to ACE-inhibitor, enalapril1 (absolute risk reduction: 4.7%).
 

 

January 19, 2016
Swedish Orphan Biovitrum AB (publ) (Sobi) announced that the European Patent Office (EPO) has decided to grant a European patent for the Orfadin® (nitisinone) oral suspension formulation

Swedish Orphan Biovitrum AB (publ) (Sobi) announced that the European Patent Office (EPO) has decided to grant a European patent for the Orfadin® (nitisinone) oral suspension formulation, which was approved by the European Commission for the treatment of Hereditary Tyrosinaemia type-1 (HT-1) in 2015. HT-1 is a rare genetic disease that affects infants and children. It is progressive and may result in liver and kidney complications and can be fatal if untreated.

 

January 11, 2016
JINARC® (tolvaptan) is accepted for use in Scotland for the treatment of autosomal dominant polycystic kidney disease (ADPKD)

December 3, 2015
The drug, discovered and developed in Italy, is being studied in patients with neurotrophic keratitis, a pathology still lacking an effective treatment that affects fewer than five out of 10,000 individuals
November 20, 2015
First irreversible proteasome inhibitor for relapsed multiple myeloma approved in the European Union

Approval based on data from pivotal Phase III ASPIRE trial, which demonstrated patients treated with kyprolis in combination lived nearly nine months longer without disease progression compared to common treatment course.
 

 

September 25, 2015
Positive opinion from EU review body puts Entresto (sacubitril valsartan) on track to be approved for HFrEF patients across Europe by the end of 2015

Novartis announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Entresto™ (sacubitril valsartan). Pending final approval by the European Commission (EC), Entresto (sacubitril valsartan), previously known as LCZ696, will be licensed for use in the UK for the treatment of adult patients with symptomatic chronic heart failure and reduced ejection fraction (HFrEF).

 

September 14, 2015
Daklinza in combination with sofosbuvir is the first 12-week all-oral therapy for genotype 3 patients without cirrhosis in Europe

Bristol-Myers Squibb Company announced that the European Commission has approved an updated label for Daklinza for the treatment of genotype 3 chronic hepatitis C (HCV). The update allows the use of Daklinza in combination with sofosbuvir for 12 weeks in patients without cirrhosis in all 28 Member States of the European Union, and marks the first time these patients with genotype 3 HCV have a once-daily, all-oral treatment regimen of this shorter duration.

 

September 4, 2015
NICE recommends RoActemra® (tocilizumab) as monotherapy for treatment of severe rheumatoid arthritis

As many as 20,000 patients in England and Wales with severe rheumatoid arthritis (RA) could soon benefit from RoActemra monotherapy, after the National Institute for Health and Care Excellence (NICE) issued a positive Final Appraisal Determination (FAD), recommending the medicine for use on the NHS.

 

August 27, 2015
NICE recommends vedolizumab as an option for adults with moderately to severely active Crohn’s Disease (CD) who have either failed,* or were intolerant or contraindicated to, a tumour necrosis factor alpha inhibitor (anti-TNF) (1)
July 3, 2015
Duodopa® (Levodopa-carbidopa intestinal gel) recommended through NHSE’s specialised commissioning prioritisation process

AbbVie welcomes the decision by NHS England to approve Duodopa® (Levodopa-carbidopa intestinal gel – LCIG) for routine commissioning for the first time and to publish a clinical commissioning policy. Doctors in England will now be able to prescribe the treatment as an option for those people with advanced Parkinson’s who they consider to be suitable, in line with the new policy.

 

July 1, 2015
Nivolumab is the first PD-1 (programmed death-1) immune checkpoint inhibitor to be licenced for advanced melanoma in the EU and works by stimulating the body’s own immune system to fight cancer

Bristol-Myers Squibb announced the UK launch of Opdivo® (nivolumab), as monotherapy, for the treatment of adult patients with advanced (unresectable or metastatic) melanoma, regardless of BRAF status. It is the first in a new class of medicines – PD-1 immune checkpoint inhibitors – to be licenced in the EU and works by harnessing the body’s own immune system to fight cancer. (1)  

 

June 29, 2015
The specialty global pharmaceutical company has acquired Idis Group Holdings Ltd to create the market leader in the ethical unlicenced supply of medicines

 Burton-on-Trent based Clinigen Group plc., the specialty global pharmaceutical company, has acquired Idis Group Holdings Ltd to create the market leader in the ethical unlicenced supply of medicines following £106 million in funding from Santander Corporate & Commercial, Royal Bank of Scotland and HSBC. Idis has been acquired for an enterprise value of £225 million.
 

June 26, 2015
Novo Nordisk announced that the Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the expanded use of Levemir® (insulin detemir) in children with diabetes as young as one year old

There are an estimated 497,100 children living with type I diabetes globally and incidence is increasing in many countries. (1) Young children with type I diabetes can be difficult to treat as their needs are in constant flux during growth and development, (2) with children aged six and under at greatest risk of severe hypoglycaemia and acute diabetes complications. (3)
 

 

June 26, 2015
Adults with non-radiographic axial spondyloarthritis can be considered for once-monthly subcutaneous injection with SIMPONI® (golimumab)

MSD (Merck & Co., Inc., Kenilworth, New Jersey, USA) announced that on 22 June the European Commission approved SIMPONI® (golimumab) for the treatment of adult patients with severe, active non-radiographic axial spondyloarthritis (nr-axial SpA). This follows CHMP positive opinion issued in May 2015, (1) based on the findings from the GO-AHEAD study, which demonstrated significant clinical improvement in patients with active nr-axial SpA treated with SIMPONI®, compared with patients treated with placebo, over 16 weeks. (2)

 

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